For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances. Mr. President, this is a unique opportunity for you to reset our approach to this crisis. As a first step, we need to reassess the enforcement-first approach of the past several years.

Before I go further, I would like to make a few things very clear.

I have a tremendous amount of respect for law enforcement. My father was a police officer for more than 24 years and I greatly admire the law enforcement personnel I had the pleasure of working with in my 12 + years at the Department of Justice.

While many of the recent past administrators of DEA came from DEA and law enforcement backgrounds, this is not a criticism of the work they did. This is also not a criticism of DEA’s and state and local law enforcement’s approach to addressing the issue. Rather, this is about taking a different approach to combating the prescription drug abuse epidemic.

Now that I have gotten that out of the way, let me explain myself. The prescription drug abuse epidemic has continued in this country for more than a decade. The Office of National Drug Control Policy, DEA, and others have repeatedly stated that enforcement alone will not solve the problem. Refreshing in this day and age, I think that is something that we can now all agree on. What we can’t seem to agree on is how to make real measurable progress in addressing the root causes of prescription drug abuse and to stop prescription drug abuse from turning into addiction.

Reassessing the enforcement first approach and perhaps appointing someone from outside of the law enforcement community as the next Administrator would be a good first step in making measurable progress. Enforcement has been DEA’s and state and local law enforcement’s default response to prescription drug abuse. Let’s be fair. Reporting arrest and seizure statistics are an easy way to show progress, right? Unfortunately, that is not the case with the prescription drug abuse epidemic. DEA has long discussed the balloon effect of its enforcement efforts. That is to say, you squeeze the balloon in one area and another area grows. Despite the realization that addressing controlled substance diversion operates in nearly the same manner, enforcement first seems to be the agency’s go-to response. Again, an observation and not a criticism.

DEA is first and foremost a law enforcement agency. DEA personnel say as much at conferences – “enforcement is our middle name.” It has shown to be uncomfortable in its own skin when operating as a regulator. Instead of looking at everyone as a potential “bad guy,” a regulator must collaborate, educate, and work with the regulated industry, using enforcement as a last option and for the most egregious misconduct. Moreover, a regulator must understand how its regulated industry operates and should stay on top of technological and process advancements in the regulated industry.

Perhaps it is time for a change in addressing prescription drug abuse. An approach that is in line with how the Food and Drug Administration (“FDA”) operates would be a good starting point. Publishing guidance on its website that it provides to registrants should be a no-brainer. Currently, DEA will meet with industry groups and respond to individual letters from registrants seeking guidance. On a daily basis DEA is providing guidance to registrants, but does not share such guidance on its website. Same for when DEA speaks to industry groups. A more educated registrant population will lead to a more compliant registrant population, which will ideally lead to less diversion of controlled substances.

Another approach may be to appoint a DEA Administrator, from outside the ranks of law enforcement, who may bring a different perspective to the job. I am not advocating bringing someone who will treat industry with kid gloves. We need someone with a willingness to work with DEA registrants first, while using enforcement as a last resort. Of course, there will always be the most egregious cases where enforcement as the primary tool must be used. But, as DEA has acknowledged, only a very small percentage of the approximately 1.7 million DEA registrants are actively engaged or otherwise involved in the diversion of controlled substances. DEA registrants fund the Diversion Control Division through registration fees. Instead of using the registrant community’s money for additional enforcement mechanisms, such as tactical diversion squads or Special Assistant United States Attorneys, perhaps non-enforcement options can be funded to better educate and collaborate with the registrant community. I understand that DEA does provide some education and training for registrants, but it can certainly do more. Prescribers of controlled substances should be DEA’s main focus.

As a law enforcement agency, DEA is also understandably opaque when it comes to managing the regulatory aspect of its Congressional mandate. Perhaps a leader outside of law enforcement will move the agency to be more transparent with the regulated industry. Appointing someone without a law enforcement background is obviously not the silver bullet that will eradicate prescription drug abuse. It is, however, time for a new perspective and a new approach to addressing prescription drug abuse. Taking a different approach when choosing DEA leadership and regulating DEA registrants may be a good first step.

]]>The Other Side of the Story: DEA Enforcement in the Opioid Crisishttp://deachronicles.quarles.com/2017/10/the-other-side-of-the-story-dea-enforcement-in-the-opioid-crisis/
Wed, 18 Oct 2017 21:24:43 +0000http://deachronicles.quarles.com/?p=1912Continue Reading]]>Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of course journalism and takes a strong position against drug companies. Aided by reporters from the Washington Post and former employees from the Drug Enforcement Administration (“DEA”), the 60 Minutes segment, while dramatic in its presentation, only told the facts relevant to the position it was taking – which is what makes good headlines.

In the segment, a former employee of DEA provided heartfelt and explicit accusations that drug companies, through their lobbyists – especially drug wholesalers – were responsible for the drug epidemic, placing profit above public health and safety. The accusations oversimplify the problem and attribute causation unfairly rather than looking at the totality of the circumstances and the contributing factors. Moreover, the attribution of decreased enforcement to recent legislation amending the Controlled Substances Act was incomplete and unbalanced.

Despite repeated finger pointing against certain members of the supply chain, the DEA employee made no mention of the two vitally important factors related to the surplus of controlled substances in our communities – DEA controls on manufacturing and over-prescribing by some physicians (or other prescribers). There did not seem to be a significant effort on the part of the reporters to challenge the former DEA employee’s assertions or attempt to look at the plethora of factors influencing the prescription drug abuse epidemic.

One significant factor that is often overlooked by reporters, policymakers, legislators, and the general public is that the total quantity of the most widely abused and diverted controlled substances produced and available in the United States is controlled and set by DEA. Even if the claim that Big Pharma’s lobbyists persuaded Congress to legislate in its favor is true, DEA still has the power and autonomy to limit the pharmaceutical company’s profits, by limiting the amount of drugs that can be produced. Unless, of course, the former employee is also insinuating that DEA itself was beholden to drug lobbyists.

Instead of using its significant authority to limit the supply of these widely abused controlled substances, DEA actually became complicit in the problem by allowing significant increases in the manufacturing of these substances while the prescription drug epidemic was exploding. It is more than a bit of irony that the same former DEA employee blaming the epidemic on the regulated industry was the one whose hand was on the spigot, setting and approving the annual quota from approximately 2006 through 2016 – the heart of the prescription drug abuse epidemic. To be clear, these were not small increases over time (oxycodone quota increased by more than 300%). The graphics below show DEA-issued quota from 2004 through 2013.

While much attention is given to the bill passed by Congress and signed by President Obama, there was shockingly no reference to the actual content of the legislation which was only 7-pages long. The bill did not strip DEA’s enforcement authority. It clarified an important legal term/standard that had not previously been defined. Instead of reporting both sides of the issue, 60 Minutes left its viewers thinking that one act of Congress crippled an entire agency’s enforcement operation. That is disingenuous at best. It is well known that administrative enforcement actions, including Immediate Suspension Orders, came to a screeching halt three years prior to the passage of the legislation in question. This was due to a number of factors that were not explored.

Also absent from the reporting is any discussion or acknowledgment that over-prescribing of controlled substances is at the heart of the prescription drug abuse epidemic. We need to ask (and hopefully answer) a fundamental question – why do prescribers in the United States prescribe the overwhelming majority of opioids that are consumed in the world? DEA, state regulators, and trade associations, including the AMA, must not only hold prescribers accountable, but they must educate prescribers and significantly change prescribing practices and the medical approach to treating pain. Minimal credits in prescription drug abuse, treating pain, and prescribing opioids should be required for all attendees of medical colleges and universities. State medical boards should require minimum CME requirements every year for these same topics. And perhaps we need to consider limiting the authority to prescribe opioids to certain types of practitioners.

Finger-pointing and Monday-morning quarterbacking only deflect our attention from addressing this serious epidemic. There is no shortage of great minds inside and outside of government, who, when working together can make measurable progress in protecting the public health and safety from prescription drug abuse. Treating pharmaceutical companies as “drug dealers in lab coats” is the failed approach of previous management at DEA. While maybe not the silver bullet, I expect that collaboration with industry will bear more positive results.

The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month. The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.

In addition to the information generally provided to regulators, the form requires the wholesaler to disclose the reason it classified the order as suspicious. If a wholesaler had no suspicious orders to report in a given month, the form also must be used to disclose that fact to the Board. The “zero reporting” requirement for suspicious orders is new. It was included in proposed changes to the Board’s suspicious order reporting rule—W. Va. Code St. R. § 15-2-4—which have not yet been formally adopted by the State.

The Board notified at least one wholesaler at the end of September that it must start using the new form. Charles “Buck” Selby, the Board’s Chief Compliance Officer, stated in the letter: “[The BOP] approved this form as a required report form to be used by every controlled drug wholesale facility shipping into our state. It is the only form to be used by a wholesale facility for issuing suspicious orders reports to the West Virginia Board of Pharmacy.” Mr. Selby stated the Board was trying to improve its review of suspicious orders after receiving “much adverse publicity and comments” in recent months about the way the Board previously handled suspicious order reports.

In its rush to implement these new requirements, the Board either failed to account for or simply disregarded the fact that most wholesalers have systems in place to electronically report suspicious orders, and other required reports, to DEA and state regulators. Insisting on a paper form will significantly burden wholesalers. Perhaps more importantly, requiring a justification for why the order was flagged as suspicious is a meaningless and unhelpful burden to impose on wholesalers. As stated repeatedly by DEA and the courts, a suspicious order does not necessarily mean that diversion is occurring. The vast majority of orders reported as suspicious are suspicious only because they triggered a red flag based on volume, pattern, or frequency—the metrics listed in DEA’s regulations to define a suspicious order. Hopefully, the Board will work with wholesalers to allow the electronic filing of suspicious order reports and will reconsider its insistence on requiring a justification for categorizing an order as suspicious.

]]>Taxing Opioids to Address Prescription Drug Abusehttp://deachronicles.quarles.com/2017/07/taxing-opioids-to-address-prescription-drug-abuse/
Wed, 05 Jul 2017 17:12:02 +0000http://deachronicles.quarles.com/?p=1890Continue Reading]]>Federal and state policy makers struggle to come up with solutions to the ongoing opioid crisis. As with many areas of public policy, political leaders are turning to the tax laws as a possible way to curtail opioid abuse. In the past two years, there have been many proposals to impose special or excise taxes on the sale of opioids. To date none have passed. But we believe that without the implementation of other policies to address the issue, a number of states will impose taxes in the coming year.

In March, West Virginia Senator Joe Manchin introduced a bill (S 523) that would impose a federal excise on opioid sales. The law would impose a one cent per milligram tax on the sale of active opioids by a manufacturer, producer, or importer. Prescription drugs used exclusively for the treatment of opioid addiction as part of a medically assisted treatment effort would be exempt. The revenue would be earmarked for state run addiction treatment programs. A similar bill was introduced in the House (HR 2038).

More recently, lawmakers in Delaware were the latest to propose the tax. On June 22, the House Majority leader co-sponsored a bill (HB 250) that would impose a ten percent tax on the sellers of opioids. It would apply to manufacturers, producers, importers, and distributors of opioids in the state. It would exempt opioids used to treat opioid addiction. Opioids sold outside of Delaware would also be exempt from tax. The tax would be imposed at the wholesale level on the first sale into the state.

There have been proposals to tax opioids in seven other states in the past year. The Delaware proposal is a gross receipts tax. An almost identical tax was proposed in Pennsylvania (SB 1213) and Connecticut (SB 5) although the rate in Connecticut was lower (6.35 percent). Some states have proposed a unit tax or fee on prescription opioids. For example, Washington state lawmakers proposed a .05 cents per dose (HB 1505) while proposals in California (AB 1512), Kentucky (HB 467), Massachusetts (HB 2633), and Minnesota (HF 1440) would set the rate at one cent per one milligram dose. In every state, the revenue would be earmarked for opioid addiction treatment or law enforcement.

There are a myriad of policy and legal issues surrounding the taxation of opioids. The taxes will likely make health care more expensive. And there are Federal laws prohibiting taxation of Medicare Part D prescriptions. There are also many variations of the state tax proposals. From a policy perspective, will the taxing of opioids really impact prescription drug abuse or are lawmakers missing the mark on how to make significant gains in eradicating drug abuse?

Contact David Brunori for additional issues regarding this or other matters involving federal, state or local taxes.

The facts here were not on Masters’ side, making them less than a sympathetic petitioner. In a time where the opioid crisis is now considered an “epidemic” and garnering attention at the highest levels, it was likely difficult for the Court to justify overturning the DEA’s Final Order in a case where the petitioner: distributed large quantities of controlled substances to pharmacies that it knew or should have known were dispensing controlled substances for other than legitimate medical purposes; failed to follow its own policies and procedures; ignored/overlooked questions from its own employees regarding the distributions and allowed the drugs to be shipped anyway; and has been in trouble with the Agency before for similar misconduct.

These “bad facts” led to a decision that will have a significant impact on suspicious order detection and reporting across the industry. In affirming the DEA’s decision, the Court interpreted the suspicious order reporting requirement much more broadly than DEA. 21 C.F.R. § 1301.74(b) provides that non-practitioner registrants must design and implement a system to disclose suspicious orders of controlled substances. This regulation defines suspicious orders as “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” Consistent with DEA’s past guidance, the Court agreed that the criteria listed in DEA’s regulations for determining whether an order is suspicious is not an exhaustive list. The Court, however, then went on to take a less nuanced view on what must be reported to DEA under this regulation. DEA field division offices across the country have historically differed on how they interpret their own regulations. Some offices demand that registrants provide notice of all orders that are flagged by the registrant’s suspicious order monitoring program, while others only want orders reported that are deemed to be suspicious after the registrant has conducted an investigation of the order. The Court’s decision clearly supports the former reporting system. Arguably, the Court left open the possibility that flagging an order and investigating the order before reporting to DEA could satisfy a registrant’s reporting obligations. The Court cautioned registrants that if they “choose to shoulder the burden of dispelling suspicion in hopes of shipping…” then the distributor must conduct a detailed investigation each and every time in attempting to resolve the suspicion. On the contrary, the Court clearly states that “it is not necessary for a distributor of controlled substances to investigate suspicious orders if it reports them to DEA and declines to fill them.” With that said, it is difficult to envision a scenario where the flag and investigate approach would not violate the reporting requirement, especially where the Court’s unanimous view is that all orders that are flagged based on objective mathematical criteria designed to identify unusual volume, pattern, or frequency fall within the “suspicious order” definition of the regulations.

While the Masters case was obviously an important win for DEA, there are significant collateral consequences for the Agency. Whether a company utilizes an off-the-shelf product or has developed its own methodology for detecting and reporting suspicious orders, all suspicious order monitoring programs rely on objective mathematical criteria based on historic ordering patterns. As DEA has ramped up enforcement action against distributors the past ten or so years, many registrants have become more conservative in their monitoring of orders and reporting as suspicious orders flagged by their monitoring systems. The Masters decision may result in more registrants simply reporting every order flagged by their monitoring systems instead of conducting an investigation to determine whether the order should really be reported as suspicious. In turn, this could lead to DEA receiving voluminous amounts of suspicious order reports, making it more difficult for the Agency to use the data as a means of investigating potential bad actors within the system.

Perhaps the Masters decision will prompt DEA to take meaningful action, by working with the industry it regulates to figure out a better way to monitor for and report suspicious orders. Reporting orders that are truly suspicious provides useful investigative tools for DEA, whereas reporting all orders that are flagged by a mathematical algorithm is a frankly less than helpful exercise. If DEA really wants to make meaningful progress in combating the opioid epidemic, then it should create a working group with subject matter experts and representatives from industry to develop new suspicious order regulations. If DEA continues to be unwilling to do so, then it is going to need a lot more storage space to accommodate the influx of data coming its way.

Disclosure: The author submitted an amicus brief in this matter on behalf of a client.

]]>Oregon Adds Suspicious Order Reporting to Wholesale Distributor Requirementshttp://deachronicles.quarles.com/2017/06/oregon-adds-suspicious-order-reporting-to-wholesale-distributor-requirements/
Mon, 19 Jun 2017 14:58:55 +0000http://deachronicles.quarles.com/?p=1853Continue Reading]]>Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017.

The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA).

The new regulation states:

A wholesale distributor must notify the Board in writing of suspicious orders of controlled substances to be distributed in Oregon upon discovery. Suspicious orders include, but are not limited to orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. OAR 855-065-0010.

The Board is hopeful that this new regulation will lead to a better system of controlled substance reporting, and will prove an effective way for the state to monitor and minimize the effects of the ongoing opioid epidemic.

]]>DEA Decisions: In the Matter of Wesley Pope, M.D.http://deachronicles.quarles.com/2017/03/in-the-matter-of-wesley-pope-m-d/
Mon, 27 Mar 2017 00:45:56 +0000http://deachronicles.quarles.com/?p=1830Continue Reading]]>An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be granted a new registration, but placed on probation for one year. Acting Administrator Chuck Rosenberg disagreed. He reviewed the case and concluded that DEA proved that the doctor knew the patient was abusing or diverting the drugs and prescribed anyway. Dr. Wesley Pope’s application for a new DEA registration was denied as inconsistent with the public interest.

Summary of the Issues

In the Final Order, published on March 23, 2017, Acting Administrator Chuck Rosenberg on several occasions disagreed with, questioned, or rejected the rationale of Chief Administrative Law Judge John J. Mulrooney, II. The three main issues were: (i) whether the Oklahoma Medical Board’s record-keeping requirements for the treatment of chronic pain were permissive or mandatory; (ii) whether the prescriptions were issued for a legitimate medical purpose in the practitioner’s usual course of professional practice under federal law; and (iii) whether Public Interest Factor #2 (the practitioner’s experience in dispensing controlled substances) should take into account a practitioner’s track record of lawful dispensing or if, instead, DEA can focus on the practitioner’s alleged bad acts.

Summary of the Facts

Dr. Pope, of Newcastle, Oklahoma, wrote 19 prescriptions between August 2011 and May 2012 for a 27-year-old male patient whose primary complaint was low back pain. At the same time, the patient was being treated by a psychiatrist for depression and anxiety and was being prescribed Xanax (generic name: alprazolam). The patient was required to take multiple drug screens, several of which came back with arguably aberrant results, including one test that detected no alprazolam, even though the patient was being prescribed alprazolam every month, and one test that showed no morphine in the patient’s system, even though morphine had been prescribed within the previous 30 days. Dr. Pope came to the authorities’ attention on May 10, 2012, when the patient was found semiconscious and intoxicated in a vehicle parked on the center median of a highway in Norman, Oklahoma. The patient had several prescription bottles of opiate pain killers in the car that had been prescribed by Dr. Pope, and, according to police, a search of his cell phone indicated he was illegally buying and selling prescription drugs. The police also found sexually explicit text messages between Dr. Pope’s cell phone and the patient. At the time, Dr. Pope’s medical license was on probation for a past incident involving prescribing controlled substances to someone with whom he was having a sexual relationship.

The Administrator rejected the Chief ALJ’s dismissal of much of the Government’s expert’s testimony, stating that the Chief ALJ got Oklahoma’s pain management regulations wrong.

The government’s expert in pain management stated that, under Oklahoma law, a doctor prescribing controlled substances for pain must adequately document in the patient’s chart that he or she evaluated the patient’s chief complaint, other treatments the patient had undergone, the patient’s ability to function in daily life in light of the pain, and whether the prescribing of controlled substances provided a therapeutic benefit. The expert concluded that Dr. Pope failed to do that and, thus, failed to issue prescriptions that were valid under state law.

The Chief ALJ declined to give weight to much of the expert’s testimony. He said that the record-keeping requirements were permissive, rather than mandatory. It is “not the documentation of the medical determination that carries the day here,” according to the Chief ALJ. “Rather, it is whether the evidence supports the [doctor’s] proposition that he made such a determination . . . .” 82 Fed. Reg. 14944, 14980 (March 23, 2017).

Acting Administrator Rosenberg sided with the expert. He concluded that Oklahoma law requires a doctor engaged in treating patients with controlled substances for chronic pain to document: the nature and intensity of the pain; current and past treatment for pain; any underlying or coexisting diseases or conditions; the effect of the pain on physical and psychological function; and any history of substance abuse. Dr. Pope did only a superficial evaluation of the patient’s purported pain complaint, his medical history, and the effect of the pain, and he performed only a cursory exam that did not support the medical diagnosis, according to the Administrator. As a result, Dr. Pope never established medical necessity and none of the prescriptions were validly issued to the patient, the Administrator said.

The Administrator and the Chief ALJ also departed significantly on their interpretation of whether and when an Oklahoma doctor who is treating a patient with controlled substances for chronic pain should refer the patient to a mental health expert or consult with other providers when the patient also suffers from depression, anxiety, or both. The Chief ALJ interpreted the Government’s expert’s testimony as stating that the Oklahoma Pain Management regulations include a “mandatory mental health referral requirement.” The Chief ALJ rejected that as inaccurate. The Administrator, in contrast, concluded that the expert was saying that Oklahoma law requires a doctor to use sound clinical judgment in determining whether a referral or consultation is necessary. Dr. Pope never referred the patient to an addiction specialist, never consulted with the patient’s mental health provider, and never documented his reasoning. According to the Administrator, “there is ample evidence . . . that [Dr. Pope] breached the standard of care when he failed to even consult with [the patient’s] mental health providers.” Id. at 14972.

The Administrator held that all of the controlled substance prescriptions issued to the patient violated 21 C.F.R. § 1306.04(a) because none of them were issued for a legitimate medical purpose by a doctor acting in the usual course of his professional practice.

Just as the Administrator found that the prescriptions were invalid under state law, he found that they were invalid under federal law because no medical necessity was ever established and because, when the doctor continued prescribing without resolving aberrant drug screenings, without getting details when the patient stated that his prescription drugs were stolen, and without assessing whether controlled substances were helping the patient achieve his stated goal of returning to work, the doctor was acting outside of the usual course of professional practice.

Dr. Pope issued some of the Schedule II prescriptions without seeing the patient. The Administrator noted that 21 C.F.R. § 1306.12(b) permits a practitioner to issue multiple prescriptions for a Schedule II drug to provide up to a 90-day supply based on seeing the patient only every 90 days, but a practitioner who does so must have established: (a) medical necessity, (b) legitimate therapeutic benefit, and (c) that the patient does not have a high-risk of abuse. The Administrator concluded that Dr. Pope had not done any of those things.

The Chief ALJ argued that DEA, over the years, has obliterated any difference between Public Interest Factor #2 and Public Interest Factor #4.

A DEA registration application can be denied if the registration would be inconsistent with the public interest. 21 U.S.C. § 823(f). There are five factors to consider in making the public interest determination. The Chief ALJ stated that DEA “has been engaged in a deliberate winnowing of the scope of Factor 2, [the applicant’s experience in dispensing controlled substances], to the extent that . . . it now largely mirrors the considerations found in Factor 4,” [compliance with state, federal, and local controlled substance laws]. Id. at 14981. He argued that a practitioner’s track record of lawfully prescribing controlled substances might be a significant consideration under Factor 2. Id. The Acting Administrator pushed back against that argument. He said: Nowhere “is there any support for the notion that Congress deemed the quantitative volume of a practitioner’s dispensings to be a significant consideration in making findings under the experience factor.” Id. at 14982. DEA has given “no more than nominal weight to a practitioner’s evidence that he has dispensed controlled substances to thousands of patients in circumstances that did not involve diversion,” according to the Administrator, because no amount of legitimate dispensings can change the fact that flagrant violations of the law are inconsistent with the public interest. Id. (internal citations omitted).

Conclusion

Once the Administrator determined that the prescriptions violated federal law, he focused on what the Chief ALJ called Dr. Pope’s “almost dogged determination to accept no responsibility for his actions.” Id. at 14985. This was problematic for Dr. Pope because “where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.” Id. at 14985 (citing Medicine Shoppe—Jonesborough, 73 Fed. Reg. 364, 387 (2008). Administrator Rosenberg denied Dr. Pope’s application, effective March 16, 2017.

Last week, the U.S. Surgeon General, Dr. Vivek H. Murthy, sent a letter to 2.3 million American health professionals asking them to lead a national movement to “turn the tide” on the nation’s prescription opioid epidemic. After visiting communities hardest hit by the opioid epidemic, Dr. Murthy’s appeal to clinicians was personal:

“Everywhere I travel, I see communities devastated by opioid overdoses. I meet families too ashamed to seek treatment for addiction. And I will never forget my own patient whose opioid use disorder began with a course of morphine after a routine procedure.”

Dr. Murthy wrote that health care providers “have the unique power to end the opioid crisis.” He asked providers to commitment to this cause by pledging to:

Educate ourselves to treat pain safely and effectively.

Screen our patients for opioid use disorder and provide or connect them with evidence-based treatment.

Talk about and treat addition as a chronic illness, not a moral failing.

Consistent with these aims, the letter also included a pocket guide to help physicians implement the CDC Opioid Prescribing Guidelines.

This letter marks the first time that the Surgeon General has reached out to health care professionals directly. Next, Dr. Murthy will be writing to the nation when the first-ever Surgeon General’s report on alcohol, drugs and health is released later this year.

More information about the Surgeon General’s appeal to clinicians to “turn the tide” on the prescription drug epidemic can be found in the HHS press release.

Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research.

In a letter to the governors of Rhode Island and Washington and a resident of New Mexico, who had asked that marijuana be removed from Schedule I, DEA Acting Administrator Chuck Rosenberg said it is wrong to think of the federal drug schedules “as an escalating ‘danger’ scale,” like the Richter scale for earthquakes. Instead, he said, the schedules are determined by statutory criteria based on medical and scientific evidence.

DEA cannot reschedule marijuana, Rosenberg said, because an analysis by FDA and the National Institute on Drug Abuse (“NIDA”) showed marijuana’s effectiveness in treating medical conditions has not been proven; it has a high potential for abuse; and it lacks accepted safety for use under medical supervision. DEA’s full responses to the rescheduling petitions are available here and here.

DEA’s decision to keep marijuana in the class of drugs with “no currently accepted medical use” puts the federal government at odds with 25 states and the District of Columbia, all of which have passed laws allowing the use of marijuana for medical purposes.

Rosenberg said that marijuana must be studied further in scientifically-valid, well-controlled clinical trials under investigational new drug applications. He also said that the drug approval process is the proper way to assess whether a product derived from marijuana or its constituent parts is safe and effective for medical use.

DEA will increase the number of authorized marijuana manufacturers that supply researchers

Also on Thursday, DEA announced a policy change that will expand the number of DEA-registered marijuana manufacturers. The move could provide researchers with a more varied and robust supply of marijuana. Currently, only the University of Mississippi is authorized to grow marijuana for the 350 individuals and institutions registered to research marijuana, marijuana extracts, derivatives, and tetrahydrocannabinols (“THC”). Research is being conducted on marijuana’s effectiveness in treating conditions such as epilepsy and chronic pain, among others.

“[W]e will – as we have for many years – support and promote legitimate research regarding marijuana and its constituent parts,” Rosenberg wrote in the letter. He pledged that DEA will work with NIDA to ensure that there is a “sufficient supply of marijuana and its derivatives (in terms of quantity and the variety of chemical constituents) to support legitimate research needs.”

]]>Improving Regulatory Transparency for New Medical Therapies Act Heading to the President as Amended by the Senatehttp://deachronicles.quarles.com/2015/11/improving-regulatory-transparency-for-new-medical-therapies-act-heading-to-the-president-as-amended-by-the-senate/
Mon, 23 Nov 2015 16:41:30 +0000http://deachronicles.quarles.com/?p=1739Continue Reading]]>

On November 16, 2015, the House of Representatives agreed to the Senate’s amended version of the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639). We previously described how the version of H.R. 639 originally passed by the House gave manufacturers clarity and security on the timing of DEA actions related to the entrance of new drugs into the market. The Senate’s amendment maintains these provisions and then sweetens the deal, with one exception.

Now, H.R. 639 incorporates the provisions of H.R. 2340, another bill introduced this session by Congressman Pitts. These provisions amend the Controlled Substances Import and Export Act to remove regulatory barriers to the re-exportation of controlled substances among members of the European Economic Area (the free trade zone uniting the EU member states and Iceland, Liechtenstein, and Norway) (“EEA”). The Controlled Substances Act (“CSA”) and DEA regulations currently impose conditions under which a drug in Schedule I or II or a narcotic drug in Schedule III or IV may be exported to a “first country” and then re-exported to one or more than one “second country.” If H.R. 639 becomes law, re-exportation within the EEA would change in the following ways:

Controlled substances could continue to be re-exported among EEA countries if each exporting country and each importing country would otherwise meet the conditions required by the CSA for subsequent export from a “first country” to a “second country.”

Within 30 days following each re-exportation within the EEA, the U.S. exporter must provide the DEA with documentation certifying that the re-exportation has occurred as well as information concerning the consignee, country, and product.

The DEA cannot impose or enforce any regulation or policy which “impedes re-exportation of any controlled substance among [EEA] countries,” including any requirement that “information concerning the consignee, country, and product be provided prior to exportation of the controlled substance from the [US] or prior to each re-exportation among members of the [EEA].”

What’s Lost: H.R. 639 does not allow interested parties to comment or request a hearing in response to a DEA interim final rule controlling a new drug

The Senate’s amendment to H.R. 639 eliminated the provision that allowed interested parties to initiate a proceeding regarding the DEA’s interim scheduling decision for a new drug prior to that decision becoming final. The version originally approved by the House stated that “[t]he interim final rule shall give interested persons the opportunity to comment and to request a hearing.” This version also required that such proceedings be brought to completion prior to issuance of the final rule. Now, a manufacturer must wait until the final rule is issued to appeal the controls on a new drug, and H.R. 639 does not require the DEA to do so within any certain period of time after publishing the interim final rule. However, we note Congressman Joe Pitt’s comment during Floor consideration of H.R. 639 that the DEA has not made any scheduling decision for a new drug that was contrary to the FDA recommendation since 1996. If this trend continues, interim final rules should rarely be controversial.

Like many others, we are eager for the new and improved H.R. 639 to reach the President’s desk. We will provide an update on the President’s action as soon as possible.